TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

The TriMed Ulnar Osteotomy System is a metallic bone fixation device consisting of plates and screws designed for osteotomy procedures on the ulna bone. The system includes an Ulnar Osteotomy Compression Plate, Hex Cortical Screw 3.2mm, Locking Cortical Screw 3.2mm, and Lag Screw 3.2mm, all manufactured from medical-grade stainless steel.

The TriMed system is substantially equivalent to the predicate in terms of material, design features, principles of operation, manufacturing, packaging, and labeling. The compression plate accepts 3.2mm locking and non-locking screws, with the lag screw hole accommodating a 3.2mm lag screw for additional compression at the osteotomy site. Any differences between the proposed device and predicate are considered minor and do not raise different safety or effectiveness questions.

TriMed Ulnar Osteotomy Plates were tested per FDA Guidance Document 'Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway.' TriMed screws were tested per FDA Guidance Document 'Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway.' All test samples met acceptance criteria.

The device is substantially equivalent because it shares the same indications for use (osteotomy procedures of the ulna), identical technological characteristics (material composition, plate design, screw specifications), and comparable performance based on non-clinical testing to the predicate TriMed Ulnar Osteotomy Plate (K043263). The minor design variations do not create different safety or effectiveness concerns, and both devices meet the same FDA guidance-based performance standards for bone fixation appliances.